SAFETY CONCERNS COULD LEAD TO CONDITIONAL APPROVALS

If drug safety concerns persist at current levels, the FDA could decide to expand its use of a conditional approval process that restricts the distribution of drugs -- a move that could be a mixed blessing for drugmakers that might not otherwise get their products approved, according to industry experts.

The FDA already has the ability to restrict distribution of approved drugs under 21 CFR Part 314, Subpart H: "Approval of New Drugs for Serious or Life-Threatening Illnesses." Under section 314.520 of the rule, the agency can require "such postmarketing restrictions as are needed to assure safe use."

Subpart H now applies to a relatively limited category of drugs, including those that are breakthrough products for life-threatening conditions and that have been approved on an accelerated basis, said Greg Levine, an attorney in Arnold & Porter's pharmaceutical practice. Under Subpart H, for example, the FDA can restrict distribution of products to certain facilities or physicians with special training or experience.

The use of RiskMAPs or an expanded Subpart H approval process presents both obstacles and opportunities for drugmakers in an environment of increased scrutiny on drug safety. While the change would not necessarily delay drug approvals, it would create a probationary period for all drugs that could result in a slower uptake of products and possibly reduced sales of certain drugs, Levine said.

On the plus side, the restrictions imposed by Subpart H and RiskMAPs could help open doors that previously weren't open to drugmakers. "Having a RiskMAP in place would give the FDA a comfort level about a product," Levine said. "In some circumstances, you may be able to get approval of drugs that would not otherwise be approvable."

For information about obtaining a transcript of the audioconference, go to http://www.fdanews.com/wbi/conferences/riskmaps.html (http://www.fdanews.com/wbi/conferences/riskmaps.html).